EP2098250A4 - Préparation solide se désintégrant oralement - Google Patents

Préparation solide se désintégrant oralement

Info

Publication number
EP2098250A4
EP2098250A4 EP07860401A EP07860401A EP2098250A4 EP 2098250 A4 EP2098250 A4 EP 2098250A4 EP 07860401 A EP07860401 A EP 07860401A EP 07860401 A EP07860401 A EP 07860401A EP 2098250 A4 EP2098250 A4 EP 2098250A4
Authority
EP
European Patent Office
Prior art keywords
solid preparation
orally disintegrating
disintegrating solid
orally
preparation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP07860401A
Other languages
German (de)
English (en)
Other versions
EP2098250B1 (fr
EP2098250A1 (fr
Inventor
Takashi Kurasawa
Yasuko Watanabe
Yohko Akiyama
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Takeda Pharmaceutical Co Ltd
Original Assignee
Takeda Pharmaceutical Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Takeda Pharmaceutical Co Ltd filed Critical Takeda Pharmaceutical Co Ltd
Publication of EP2098250A1 publication Critical patent/EP2098250A1/fr
Publication of EP2098250A4 publication Critical patent/EP2098250A4/fr
Application granted granted Critical
Publication of EP2098250B1 publication Critical patent/EP2098250B1/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/444Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring heteroatom, e.g. amrinone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5036Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
EP07860401.4A 2006-12-28 2007-12-27 Préparation solide se désintégrant oralement Active EP2098250B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2006356405 2006-12-28
PCT/JP2007/075179 WO2008081891A1 (fr) 2006-12-28 2007-12-27 Préparation solide se désintégrant oralement

Publications (3)

Publication Number Publication Date
EP2098250A1 EP2098250A1 (fr) 2009-09-09
EP2098250A4 true EP2098250A4 (fr) 2012-06-06
EP2098250B1 EP2098250B1 (fr) 2016-09-28

Family

ID=39588572

Family Applications (1)

Application Number Title Priority Date Filing Date
EP07860401.4A Active EP2098250B1 (fr) 2006-12-28 2007-12-27 Préparation solide se désintégrant oralement

Country Status (4)

Country Link
US (1) US9486446B2 (fr)
EP (1) EP2098250B1 (fr)
JP (1) JP5366558B2 (fr)
WO (1) WO2008081891A1 (fr)

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JP5524624B2 (ja) 2007-11-16 2014-06-18 旭化成ケミカルズ株式会社 水系フィルムコーティング液、および、フィルムコーティング顆粒、ならびに、これを用いた錠剤
GEP20135845B (en) * 2008-03-11 2013-06-10 Takeda Pharmaceutical Orally-disintegrating solid formulation
JP5399749B2 (ja) * 2008-03-27 2014-01-29 沢井製薬株式会社 プロトンポンプ阻害剤を含有する被覆微粒子
CA2729015A1 (fr) 2008-06-26 2009-12-30 Mcneil-Ppc, Inc. Particules enrobees contenant des agents pharmaceutiquement actifs
EP3031451B1 (fr) * 2009-01-26 2018-03-07 Shin-Etsu Chemical Co., Ltd Procédé de fabrication de comprimés à granulation par voie humide utilisant une dispersion aqueuse de cellulose hydroxypropyle substituée faible
JP5827952B2 (ja) * 2009-10-09 2015-12-02 ユンジン・ファーム・カンパニー・リミテッドYungjin Pharm. Co. Ltd. 速効性と持続性を同時に有する薬剤学的組成物
GB201003731D0 (en) * 2010-03-05 2010-04-21 Univ Strathclyde Immediate/delayed drug delivery
GB201003766D0 (en) 2010-03-05 2010-04-21 Univ Strathclyde Pulsatile drug release
GB201003734D0 (en) 2010-03-05 2010-04-21 Univ Strathclyde Delayed prolonged drug delivery
JP5614445B2 (ja) * 2010-03-29 2014-10-29 アステラス製薬株式会社 経口投与用粒子状医薬組成物
WO2011121824A1 (fr) * 2010-03-29 2011-10-06 アステラス製薬株式会社 Comprimé à désintégration orale
WO2011138797A2 (fr) * 2010-05-04 2011-11-10 Cadila Healthcare Limited Composition pharmaceutique de lansoprazole à action différée se désintégrant par la voie buccale
JP5615612B2 (ja) * 2010-07-21 2014-10-29 大原薬品工業株式会社 苦味を有する生理活性物質含有粒子の製造方法
JP2012046454A (ja) * 2010-08-27 2012-03-08 Lion Corp 内服用錠剤およびその製造方法
SG10201602311XA (en) * 2010-12-27 2016-04-28 Takeda Pharmaceutical Orally disintegrating tablet
JP5876418B2 (ja) * 2010-12-28 2016-03-02 大鵬薬品工業株式会社 口腔内崩壊錠剤
JP5828007B2 (ja) * 2011-12-21 2015-12-02 Meiji Seikaファルマ株式会社 局所投与型の嚥下障害改善用医薬品
CN105392486A (zh) * 2013-05-21 2016-03-09 武田药品工业株式会社 口腔崩解片
JPWO2014199486A1 (ja) * 2013-06-13 2017-02-23 Meiji Seikaファルマ株式会社 嚥下障害改善用医薬品
US9974768B2 (en) 2013-06-13 2018-05-22 Meiji Seika Pharma Co., Ltd. Pharmaceutical for improving dysphagia
KR20170083535A (ko) 2014-11-14 2017-07-18 젬파이어 세러퓨틱스 인코포레이티드 α,ω-다이카복실산-말단 다이알케인 에터를 제조하기 위한 방법 및 중간체
KR102431738B1 (ko) * 2014-12-25 2022-08-10 주식회사 다이셀 초고속 붕해 정제 및 그 제조 방법
EP3288556A4 (fr) 2015-04-29 2018-09-19 Dexcel Pharma Technologies Ltd. Compositions à désintégration par voie orale
US20160331689A1 (en) 2015-05-12 2016-11-17 SE Tylose USA, Inc. Aqueous enteric coating composition
JP6469234B2 (ja) 2015-09-04 2019-02-13 株式会社ダイセル 超速崩壊錠剤及びその製造方法
US10076494B2 (en) 2016-06-16 2018-09-18 Dexcel Pharma Technologies Ltd. Stable orally disintegrating pharmaceutical compositions
US20190008779A1 (en) * 2017-05-11 2019-01-10 Gemphire Therapeutics Inc. Gemcabene compositions and methods of use thereof
TR201820835A1 (tr) * 2018-12-28 2020-07-21 Neutec Ar Ge Sanayi Ve Ticaret Anonim Sirketi Deksrabeprazol İçeren Bir Formülasyon.
JP7404828B2 (ja) * 2019-11-29 2023-12-26 ニプロ株式会社 経口医薬製剤およびその製造方法

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0277741A1 (fr) * 1987-01-29 1988-08-10 Takeda Chemical Industries, Ltd. Granules sphériques à noyau et leur fabrication
WO1999059544A2 (fr) * 1998-05-18 1999-11-25 Takeda Chemical Industries, Ltd. Comprimes se desintegrant dans la bouche
US20040018235A1 (en) * 2002-06-17 2004-01-29 Kowa Co., Ltd Controlled release pharmaceutical composition

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JPS5163927A (en) 1974-11-28 1976-06-02 Shinetsu Chemical Co Ketsugoseiryokonajozaihokaizaino seizohoho
JPS6150978A (ja) 1984-08-16 1986-03-13 Takeda Chem Ind Ltd ピリジン誘導体およびその製造法
JPH072761B2 (ja) 1985-03-20 1995-01-18 不二パウダル株式会社 微結晶セルロ−ス球形顆粒及びその製造法
JPH0832625B2 (ja) 1987-01-29 1996-03-29 武田薬品工業株式会社 有核顆粒およびその製造法
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JP3069458B2 (ja) 1992-01-29 2000-07-24 武田薬品工業株式会社 口腔内崩壊型錠剤およびその製造法
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US8105626B2 (en) * 2001-10-17 2012-01-31 Takeda Pharmaceutical Company Limited Granules containing acid-unstable chemical in large amount
JP2005139086A (ja) 2003-11-04 2005-06-02 Ono Pharmaceut Co Ltd 速崩壊製剤
WO2006036007A2 (fr) 2004-09-30 2006-04-06 Takeda Pharmaceutical Company Limited Preparation a liberation modifiee
JP5053865B2 (ja) 2005-12-28 2012-10-24 武田薬品工業株式会社 口腔内崩壊性固形製剤の製造法

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0277741A1 (fr) * 1987-01-29 1988-08-10 Takeda Chemical Industries, Ltd. Granules sphériques à noyau et leur fabrication
WO1999059544A2 (fr) * 1998-05-18 1999-11-25 Takeda Chemical Industries, Ltd. Comprimes se desintegrant dans la bouche
US20040018235A1 (en) * 2002-06-17 2004-01-29 Kowa Co., Ltd Controlled release pharmaceutical composition

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO2008081891A1 *

Also Published As

Publication number Publication date
WO2008081891A1 (fr) 2008-07-10
US9486446B2 (en) 2016-11-08
EP2098250B1 (fr) 2016-09-28
EP2098250A1 (fr) 2009-09-09
JP5366558B2 (ja) 2013-12-11
US20100316709A1 (en) 2010-12-16
JPWO2008081891A1 (ja) 2010-04-30

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